Implementation fidelity in a complex intervention promoting psychosocial well-being following stroke: an explanatory sequential mixed methods study
Implementation fidelity in a complex intervention promoting psychosocial well-being following stroke: an explanatory sequential mixed methods study
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DOI：
10.1186/s12874-019-0694-z
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发表时间：
2019-03-15
影响因子：
4
通讯作者：
Kirkevold, Marit
中科院分区：
文献类型：
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作者：
Bragstad, Line Kildal;Bronken, Berit Arnesveen;Kirkevold, Marit
对复杂干预措施的评价应包括过程评价，以使评价者、研究人员和政策制定者对RCT报告的结果有更大的信心。实施保真度可以是过程评估的一部分，指的是根据协议提供干预的程度。这项实施保真度研究的目的是评估在何种程度上的对话为基础的心理社会干预提供了根据协议。一个修改后的概念框架实施保真度被用来指导analysis.MethodsThis研究有一个解释性的，顺序的两阶段混合方法设计。定量过程数据与RCT中的数据收集一起纵向沿着收集。在RCT的最后一个数据收集点后收集定性工艺数据。进行描述性统计分析来描述样本、干预轨迹和依从性措施。建立了一个评分系统，以澄清对执行水平的量化衡量。定性数据源进行了分析，分别与理论驱动的内容分析，使用类别的坚持和潜在的调节因素中确定的概念框架的实施保真度。从定性分析的结果，以评估哪些潜在的主持人可能会影响实施fidelity.ResultsThe结果表明，虽然干预轨迹个性化的核心组成部分的干预扩展的定量坚持结果。基于依从性的综合评分，结果显示RCT中80.1%的干预措施以高保真度实施。虽然评估每个调节因素相对于其他因素的重要性及其对遵守措施的影响具有挑战性，但参与者的反应性、政策描述的全面性、背景，在本研究中，实施忠诚度和招聘似乎是最突出的调节因素。结论实施忠诚度的评价和对高保真度实施的讨论这种干预措施对理解影响试验结果的因素至关重要。该研究还强调了研究人员规划过程评估和实施保真度研究的重要方法学考虑。试验registrationClinicalTrials.gov，NCT 02338869;注册10/04/2014。
BackgroundEvaluation of complex interventions should include a process evaluation to give evaluators, researchers, and policy makers greater confidence in the outcomes reported from RCTs. Implementation fidelity can be part of a process evaluation and refers to the degree to which an intervention is delivered according to protocol. The aim of this implementation fidelity study was to evaluate to what extent a dialogue-based psychosocial intervention was delivered according to protocol. A modified conceptual framework for implementation fidelity was used to guide the analysis.MethodsThis study has an explanatory, sequential two-phase mixed methods design. Quantitative process data were collected longitudinally along with data collection in the RCT. Qualitative process data were collected after the last data collection point of the RCT. Descriptive statistical analyses were conducted to describe the sample, the intervention trajectories, and the adherence measures. A scoring system to clarify quantitative measurement of the levels of implementation was constructed. The qualitative data sources were analyzed separately with a theory-driven content analysis using categories of adherence and potential moderating factors identified in the conceptual framework of implementation fidelity. The quantitative adherence results were extended with the results from the qualitative analysis to assess which potential moderators may have influenced implementation fidelity and in what way.ResultsThe results show that the core components of the intervention were delivered although the intervention trajectories were individualized. Based on the composite score of adherence, results show that 80.1% of the interventions in the RCT were implemented with high fidelity. Although it is challenging to assess the importance of each of the moderating factors in relation to the other factors and to their influence on the adherence measures, participant responsiveness, comprehensiveness of policy description, context, and recruitment appeared to be the most prominent moderating factors of implementation fidelity in this study.ConclusionsThis evaluation of implementation fidelity and the discussion of what constitutes high fidelity implementation of this intervention are crucial in understanding the factors influencing the trial outcome. The study also highlights important methodological considerations for researchers planning process evaluations and studies of implementation fidelity.Trial registrationClinicalTrials.gov, NCT02338869; registered 10/04/2014.